HEALM: The David Katz’ and Lifestyle Medicine Strategy to Get Randomized Controlled Trials to Share Research’s Iron Throne

HEALM: The David Katz’ and Lifestyle Medicine Strategy to Get Randomized Controlled Trials to Share Research’s Iron Throne

About the first thing one is taught in medical research is that there are hierarchies of evidence and that the “RCT” (randomized controlled trial) sits on the Iron Throne. What the integrative user of multimodal, individually-tailored approaches immediately feels is estrangement and resentment at rules that seem form-fit for pharma. Can integrative even get an audience in such a court? Now the American College of Lifestyle Medicine (ACLM) and the True Health Initiative led by Yale public health, integrative, and lifestyle medicine leader David Katz, MD, MPH have published a model that seeks to take the RCT’s down a notch. It’s a diversity play. They recommend a “systematically weighted approach” involving multiple research models that “(increase) the weight and thereby validity of evidence specially applied to lifestyle interventions.” I reached Katz for an interview in which he spoke to the model’s relationships to integrative whole system research models and of the “tyranny of the RCT”. He shares intriguing political, strategic and tactical dimensions to lifestyle medicine’s Hierarchies of Evidence Applied to Lifestyle Medicine (HEALM).

Integratively-oriented clinicians and researchers who are not utterly demoralized by the way the RCT stacks the deck against a level research playing field tend to promote whole systems research (WSR) models. Most recently these multimodal approaches were featured in this special issue of JACM (The Journal of Alternative and Complementary Medicine). Integrative researchers urge evidence democratization via concepts like the “evidence house” and the “circular model” noted below. HEALM follows in this tradition although, for strategic reasons that Katz describes, they kept their distance from WSR and the integrative community.

I first learned that HEALM was in development through one of Katz’ ACLM colleagues, Beth Frates, MD. On an ACLM webinar, Frates mentioned lifestyle medicine’s misfit with RCTs.  Perhaps because misery loves company (and insurgencies thrive on coalition and collaboration), I thought ACLM might have a thoughtful perspective to add to the JACM issue noted above on which I was working with colleagues. In an invited commentary entitled The Need for a Whole Systems Approach to Evidence Evaluation: An Update from the American College of Lifestyle Medicine, Katz and his colleague Micaela Karlsen, MSPH announced that HEALM’s potential answer to lifestyle’s misfit with RCTs was soon to be published.

Pushing the pharma-friendly RCT dominatrix to one side of the throne

In the present paper, published in BMC Medical Research Methodology, Katz, Karlsen and their team first report a systematic review of a papers on methods for evaluating “strength of evidence.” They then report that none provided guidance for 3 areas of central importance in research on lifestyle medicine interventions:

  1. Criteria to evaluate exposure-outcome relationships examined over years/decades/lifetimes
  2. Criteria to evaluate behaviors/exposures used in lifestyle medicine that may not allow for randomization or blinding (e.g., smoking, long-term dietary patterns, etc.)
  3. Guidance to synthesize findings from diverse study designs, except to prioritize RCTs over observational studies.

The team then set about a process that defined the HEALM construct as a “new method for evaluating strength of evidence for lifestyle interventions” – including RCTs but not necessarily dominated by them. The approach essentially pushes the pharma-friendly RCT dominatrix to one side of the throne to share power with other evidence methods when it comes to assessing the value of lifestyle interventions.

Perspective from U Toronto whole systems researcher Nadine Ijaz, PhD

The link between the integrative WSR work and HEALM was much on my mind when the ACLM media release arrived September 4th. I called Katz after first sending the link to Nadine Ijaz, PhD, the lead author on the remarkable Whole Systems Research Methods in Health Care: A Scoping Review (available in open access) that anchored the special issue on Multimodal Approaches in Integrative Health: Whole Persons, Whole Practices, Whole Systems. Her e-comments, with their references to the pioneering Jonas and Walach papers, are a good overview of the terrain, and linkages, from a WSR perspective.

The HEALM tool represents a valuable addition to the literature on evidence evaluation — and is likely to support dissemination of quality research that focuses on prevention and health promotion rather than sickness care alone. The tool actively contributes to (and participates in) a methodological paradigm shift that centralizes more holistic, integrative approaches in health care. The authors’ critiques of the classical RCT’s limitations with respect to behavioral interventions strongly echo those of whole systems research pioneers. Their tangible strategy for diversifying what ‘counts’ as legitimate clinical evidence recalls the ‘evidence house’ (Jonas, 2001) and ‘circular model’ (Walach et al 2006) proposals of researchers in the [Traditional Complementary and Integrative Medicine] field — and should be welcomed as such. That said, significant work remains to establish evidentiary tools that contextualize ‘lifestyle’ (and other) interventions more deeply within the social, structural and ecological determinants of health.

Katz’ prevention-integrative-lifestyle-true health contributions

Girard and Ali

Katz is a unique force in the preventive, integrative and lifestyle medicine space. His Yale-Griffin Prevention Research Center has been funded for 20 years years through the Center for Disease Control and Prevention (CDC), including an early examination of the evidence for complementary therapies. This led to Katz  groundbreaking work on “evidence mapping.” Katz’ mapping method for when one doesn’t have RCTs yet wants to make judgements, was eventually adopted in China and later by the WHO. In the late 1990s, Katz started Yale’s integrative program where he made then then outrageous choice of partnering with naturopathic physician Christine Girard, ND  – now the president of National University of Natural Medicine – in the nascent “integrative” era. They developed a unique MD-ND integrated program that was famously covered by then insurance golden boy Oxford Health Plans.  Katz sponsored researcher and clinician Ather Ali, ND, MPH – now sadly deceased – who became Katz’ Yale integrative medicine partner and internal lead, despite the fact that the two were living under the antagonistic nose of one of the most boisterous and polarizing anti-integrative academics. Katz transited smoothly to leadership in the lifestyle medicine movement at ACLM, where he was instrumental in birthing the True Health Initiative as a global policy lever for lifestyle medicine. The author and blogger is accustomed to taking on big bodacious goals – and in making headway toward them. Why not press his shoulder to help dislodge the dominance – when damaging – of the RCT?

___________________

Integrator: How radical is this?

Katz: The most popular method for measuring strength of evidence is GRADE and it depends almost entirely on RCTs. In reality there is a tyranny of the RCT – the idea that if we don’t know something via the RCT we don’t know it. But in lifestyle medicine, we are interested in lifelong effects that RCTs can’t measure, and in interventions where the placebo may be unethical. Given the growing tyranny of the RCT, this is pretty revolutionary.

Micaela Karlsen

Integrator: After you and your second author on both pieces Micaela Karlsen [MSPH] contributed to the JACM special issue on whole systems research, I of course immediately looked at the HEALM references. None directly link HEALM work to integrative medicine’s whole systems research body of work. What was that about? Why not?

Katz: We were looking to be narrow as possible in the way we approached this for this to have maximum value. We wanted it to be as conventional as possible. We want it to capture the attention of nutritional epidemiologists.  The more radical the proposal, the move conventional the case you want to make. We wanted our citations to be from researchers and journals the people we wanted to influence knew. We stuck close to our narrow proposal to do the systematic review then develop and propose the HEALM model. [Our work with HEALM] is a classic case of ‘if you can’t beat them, join them’ – then beat them by joining them,

Integrator: It looks like the advisory team you brought in also served this strategic purpose of sanctifying the effort from on high. Heavy hitters.

                   Green, Fielding and Willett

Katz: We had for advisers Larry Green [DrPH, PhD] who was the Director of the Office of Science and Extramural Research at the CDC. He’s a top systems researcher and community prevention researcher. Jonathan Fielding [MD] was the chair of the CDC’s community guide for preventive services. The UCLA Fielding School of Public Health – that’s him who it’s      named after. And Walter Willett [MD, PhD] a professor of epidemiology and nutrition at Harvard in public health. There is no one on the planet more knowledgeable about research in nutritional epidemiology than he is. He’s the most cited biomedical researcher in history.

Integrator: Your decades of connection with prevention, public health and the CDC paid off. Would you say that HEALM itself was a tactic toward policy change to advance lifestyle medicine?

Katz: Honestly I am looking to broaden people’s minds. There is a widespread debate in the peer-reviewed literature and the research community more generally about the nature of evidence for nutrition and other lifestyle interventions. An answer is never better than the the question that is asked. There is not only a tyranny of the RCT, there is a tyranny of evidence based medicine. EBM ignores the fact that whoever has the money has the evidence. Pharma has the money. But absence of evidence is not the same as evidence of absence.

Integrator: What’s an example of how the HEALM system would work.

Katz: Let’s say one approach has three RCTs and another has 2 RCTs and 4 quality observational studies. We’re saying take them both into account, not just the first.

Integrator: Probably too much common sense there to work in the medical industry.Where would you like to see this go?

Katz: I invented “evidence mapping” 20 years ago when tasked by the CDC to look at complementary medicine when systematic reviews weren’t sufficient. The evidence wasn’t there. The approach was adopted in the People’s Republic of China and then by the WHO. We are hoping to have the something similar happen with HEALM. We want those wrestling with relevant questions, who care about evidence, to use, adapt, and test the HEALM approach- and thus contribute to improvements in it, validation of it, and uptake.  Raising standards in any system takes a village- so we offer the HEALM tool to the village, or villages, of professionals who can advance understanding with its use.

Integrator: You note that it needs to be tested and validated by others. Any evidence of others interested in working with it.

Katz: The paper was circulated to the Board of ACLM and we have heard favorable reviews. There are good researchers there. The Academy of Nutrition and Dietetics is another likely place we hope to see it be put to good use.

Integrator: Getting any push-back?

Katz: I’m waiting to see if ardent RCT promoters will write to the journal. We made a point of not over-reaching, though, so perhaps we’ve dodged that bullet. I’m not sure how they could complain.  But time will tell!

Integrator: In reading it, I could almost see you on your knees giving homage to the gods of the RCT.

Katz: If you want to wage war, you take up the sword, If you want to make peace, you genuflect a little bit. We didn’t wish to look for any non-existent provocation.  Besides, I – and all of my co-authors- fully appreciate the value of the RCT.  I have published dozens!

Integrator: It looks like the Oxford Center for Evidence Based Medicine-Levels of Evidence model was the conventional method for assessing strength of evidence that is closest to what you are doing with HEALM.

Katz: Yes. What is shared is the appreciation that you have to adapt the evidence to the question. The ultimate goal of synthesizing evidence is to discover what is true. If you know what is true, you’ve won. There is a certain type of confidence needed. Does this mean that you always need to rely on RCTs? No. What if you have a few RCTs and some very good observational data. This is the model we’ve put forward.  HEALM is proposed as a tool specifically developed for lifestyle medicine and nutrition. We are encouraging its application in this domain.

Integrator: Evidence butterflies! So – here’s to being in the “evidence house” and moving room to room to build the best evidence synthesis for the question at hand. I look forward to seeing how HEALM takes off.

________________

Follow-up coming soon: Given the importance of HEALM, I devoted my October JACM column to sharing additional perspectives from the WSR community: Canadian researcher and integrative oncologist Dugald Seely, ND, Oregon Health and Science University Associate Professor of Anesthesiology Scott Mist, PhD, MAOM, MS, MA, LAc, Univesity of Toronto-affiliated Nadine Ijaz, PhD (as shared above) and a well-argued challenge from WSR researcher and Ayurvedic practitioner Jennifer Rioux, PhD, AD, C-IAYT, AYT. Stay tuned for notice in an October 2019 Integrator.

Additional point(s): One last point I can’t not make. It will be a happy day when strategic efforts such as this can be open to all the contributions from all of the interested parties. I include those in the integrative health and medicine movement who have been plowing similar ground for decades, frequently on behalf of approaches to health rooted in lifestyle medicine. They too know that behind the phrase “tyranny of the RCT” there is in truth in the tyranny: a great deal of damage is done to human health when the RCT doesn’t share the throne.